Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

NCT00593827 | Completed Phase 2 Results

• 2 other identifiers: CA163-132USOR 06-106
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 57

Brief Summary

The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months

  PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.

  From the date of randomization to 6-months on study

Secondary Outcomes (7)

• Median Progression Free Survival

  From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)

• Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]

  Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)

• Best Response as Assessed With RECIST

  Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)

• Overall Survival (OS)

  From the date of randomization to date of death (maximum participant OS of 26.3 months)

• Time to Response

  From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)

Other Outcomes (1)

• Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia

  Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest

Drug: Ixabepilone

Arm 2

ACTIVE COMPARATOR

ixabepilone 40 mg/m\^2 every 3 weeks

Drug: Ixabepilone

Interventions

Ixabepilone DRUG

Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.

Also known as: IXEMPRA, BMS-247550

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
• Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
• Prior chemotherapy is permitted with no limit on the number of prior regimens
• Two weeks or more have elapsed since last chemotherapy or radiation treatment
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
• Is female, ≥ 18 yrs of age
• Protocol defined appropriate laboratory values
• Negative pregnancy test within 7 calendar days prior to registration
• Has signed a patient informed consent

You may not qualify if:

• Had prior treatment with ixabepilone or other epothilones
• Has HER2+ disease
• Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events \[NCI CTCAE\] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
• Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
• Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
• Has peripheral neuropathy \> Grade 1
• Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
• Is pregnant or breast feeding

Sponsors & Collaborators

• R-Pharm: lead
• US Oncology Research: collaborator

Study Sites (57)

Birmingham Hematology & Oncology Associates Llc

Birmingham, Alabama, 35205, United States

Location

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Northern Arizona Hematology & Oncology Associates

Sedona, Arizona, 86336, United States

Location

Arizona Oncology Associates D.B.A. Hematology Oncology

Tucson, Arizona, 85704, United States

Location

Southwest Cancer Care

Murrieta, California, 92562, United States

Location

Florida Cancer Institute

Hudson, Florida, 34667, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

Cancer Centers Of Florida, P.A

Ocoee, Florida, 34761, United States

Location

Cancer Care & Hematology Specialists Of Chicagoland

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers

Carmel, Indiana, 46032, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Alliance Hematology Oncology, Pa

Westminster, Maryland, 21157, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Kansas City Cancer Center, Llc

Kansas City, Missouri, 64131, United States

Location

Arch Medical Services, Inc.

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Center Of Nevada

Henderson, Nevada, 89074, United States

Location

Hematology-Oncology Assoc. Of Northern Nj, Pa

Morristown, New Jersey, NJ, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

New York Oncology Hematology, P.C.

Amsterdam, New York, 12010, United States

Location

Interlakes Oncology & Hematology, P.C.

Rochester, New York, 14623, United States

Location

Regional Cancer Care

Durham, North Carolina, 27704, United States

Location

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, 27607, United States

Location

Cancer Centers Of The Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Cancer Center

Arlington, Texas, 76014, United States

Location

Texas Oncology-Central Austin Cancer Center

Austin, Texas, 78731, United States

Location

Mamie Mcfaddin Ward Cancer Center Texas Oncology

Beaumont, Texas, 77702, United States

Location

Texas Oncology

Bedord, Texas, 76022, United States

Location

Texas Cancer Center At Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology

Dallas, Texas, 75231, United States

Location

Texas Oncology/Methodist Charlton Cancer Ctr

Dallas, Texas, 75237, United States

Location

Baylor Sammons Cancer Ctr

Dallas, Texas, 75246, United States

Location

Texas Oncology Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Cancer Center

Denton, Texas, 76210, United States

Location

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

Texas Oncology

Garland, Texas, 75942, United States

Location

Texas Oncology

Houston, Texas, 77024, United States

Location

Texas Oncology - Lake Vista Cancer Center

Lewisville, Texas, 75067, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

South Texas Cancer Center

McAllen, Texas, 78503, United States

Location

Texas Cancer Center Of Mesquite

Mesquite, Texas, 75150, United States

Location

Texas Oncology, Pa

Midland, Texas, 78701, United States

Location

Texas Oncology - Odessa

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center Lab

Paris, Texas, 75460, United States

Location

Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology Cancer Center - Sugar Land

Sugar Land, Texas, 77479, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology Cancer Care And Research Center

Waco, Texas, 76712, United States

Location

Deke Slayton Cancer Center

Webster, Texas, 77598, United States

Location

Oncology & Hematology Associates Of Southwest Virginia, Inc.

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Centers

Edmonds, Washington, 98026, United States

Location

Puget Sound Cancer Centers

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

Evergreen Hematology And Oncology

Spokane, Washington, 99218, United States

Location

Northwest Cancer Specialists, Pc

Vancouver, Washington, 98684, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 10, 2016
• Results First Posted: May 25, 2012

Record last verified: 2016-02

Locations

US (57)